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Aggredyne Earns ISO 13485 Certification for Medical Device

  Aggredyne Earns ISO 13485 Certification for Medical Device

Facility recognized for quality controls in AggreGuide^TM platelet function
analyzer manufacturing

Business Wire

HOUSTON -- August 29, 2013

Aggredyne, Inc., a Houston-based biomedical diagnostics company that is
defining a new standard for platelet function, has received ISO 13485
certification for its rigorous quality control program related to the
manufacture of the AggreGuide^TM  family of platelet function analyzers.

The ISO 13485 certification covers the design, development, production, sales
and service of the AggreGuide instrument and reagent cartridges. The
certificate demonstrates that Aggredyne has successfully implemented a quality
management system that conforms to the worldwide standard for medical device
and diagnostic manufacturing.

The International Organization for Standardization (ISO) is the world's 
largest  developer and publisher of international standards. Aggredyne’s ISO
13485 certificate was awarded by National Quality Assurance (NQA).

"For any medical device manufacturer, but especially for an early-stage
company, ISO 13485 certification represents a significant growth milestone,"
said CEO Edward R. Teitel, MD. "This designation, along with our previously
earned CE Mark, recognizes Aggredyne’s commitment to provide our customers
with outstanding, high quality products and puts us on a path to increase
international sales.”

Aggredyne recently doubled the size of its facility as it prepares for it next
growth phase and expansion of its product line. “The larger facility will
enable us to meet our growing demand as we advance to our next generation
device,” said Andrew Yee, Aggredyne’s vice president of operations &


Aggredyne, Inc. ( is a biomedical company founded in early
2011 to commercialize the AggreGuide^TM platelet function analyzer. The
AggreGuide system is an in-vitro diagnostic test that measures how sticky a
patient’s platelets are and how well the patient is responding to antiplatelet
medications such as aspirin, Plavix® (clopidogrel), Effient® (prasugrel) and
Brilinta® (ticagrelor).

Registered trademarks: Plavix (Sanofi), Effient (Eli Lilly and Company),
Brilinta (AstraZeneca group of companies).


This release contains forward-looking statements as defined in the U.S.
Private Securities Litigation Reform Act of 1995. Statements in this release
that are not historical facts are “forward-looking statements,” involving
risks and uncertainties that could cause actual results to differ materially
from any future results, performance, or achievements expressed or implied by
such statements.


Edward R. Teitel, MD, JD - 713.636.5996
Sally I Evans, APR - 713.557.2461
Public Relations Counsel
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